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NOT YET RECRUITING

NCT07340320

PHASE2

A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus

Sponsor: Corxel Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is testing whether a new medication called CX11 works and is safe for participants with type 2 diabetes who have not reached good blood sugar control while taking a steady dose of metformin, with or without a steady dose of an SGLT2 inhibitor, for at least 90 days. The study is being done at multiple medical centers. Participants are assigned by chance (randomized) to different groups, and neither the participants nor the study staff know which group they're in (double-blind). The groups are compared side by side (parallel), and some participants will receive inactive pills (placebo) to help measure the true effect of the study drug. After screening, participants will be randomly placed into one of six groups, with equal chances of being in any group. Each group will receive a different dose of CX11 or a placebo. Treatment will last 24 weeks. After that, all participants will have a 2-week follow-up period to check on safety.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Finding Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

240

Start Date

2026-02-05

Completion Date

2027-01-07

Last Updated

2026-01-14

Healthy Volunteers

Conditions

Type II Diabetes Mellitus

Interventions

DRUG

CX11

CX11 tablets administered orally once daily (QD)

OTHER

Placebo

Matching placebo tablets administered orally once daily (QD)

Inclusion Criteria Participants who meet all of the following criteria will be eligible to participate in this study: * Adults aged 18 to 75. * Diagnosis of type 2 diabetes for at least 6 months. * HbA1c between 7.0% and 10.5%. * Body mass index (BMI) between 23 and 50 kg/m². * Body weight stable for the past 3 months before joining. * Stable dose of metformin, with or without a stable dose of an SGLT2 inhibitor, for at least 3 months. * Individuals who could become pregnant or could father a child must be willing and able to use highly effective birth control. Exclusion Criteria Participants who meet any of the following criteria will be excluded from this study: * Type 1 diabetes or a history of diabetic ketoacidosis. * Use of any GLP-1 receptor agonist within the past 6 months, or any prior exposure to CX11. * Use of insulin to control blood sugar within the past 12 months. * More than one episode of severe low blood sugar, with awareness of hypoglycemia symptoms. * Cardiovascular or cerebrovascular conditions within the past 6 months: * Heart attack, coronary angioplasty, or bypass surgery (diagnostic angiography allowed). * Valvular heart disease or prior heart valve repair surgery. * Unstable angina. * Transient ischemic attack (TIA) or stroke. * Decompensated heart failure (NYHA Class III or IV). * ECG abnormalities indicating significant safety risk, such as supraventricular tachycardia, torsades de pointes, second- or third-degree AV block, myocardial infarction, QTcF \> 450 ms in males or \> 470 ms in females, PR interval \> 220 ms. * Poorly controlled hypertension at screening: systolic ≥ 180 mmHg or diastolic ≥ 100 mmHg. * Pancreatic or gallbladder conditions: * Acute or chronic pancreatitis. * Symptomatic gallbladder disease. * Pancreatic injury or risk factors that increase pancreatitis risk. * Thyroid conditions: * Poorly controlled abnormal thyroid function on a stable dose before screening. * Clinically significant abnormal thyroid test results at screening. * Personal or first-degree family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type 2A or 2B. * Cancer history: * Malignancy within the past 5 years, regardless of recurrence or metastasis. Exceptions: localized basal cell skin cancer, low-risk prostate cancer, cervical carcinoma in situ, or high-grade prostatic intraepithelial neoplasia. * Gastrointestinal conditions or treatments that may affect drug absorption: * Abnormal gastric emptying (e.g., gastric outlet obstruction). * Severe chronic gastrointestinal disease, including active ulcer within 6 months. * Crohn's disease, ulcerative colitis, or other inflammatory bowel diseases. * Prior gastrointestinal surgery (except polypectomy and appendectomy). * Long-term use of drugs that directly affect gastrointestinal motility (e.g., mosapride, cisapride). * Liver disease: * Active liver disease other than nonalcoholic fatty liver. * Chronic active hepatitis B or C. * Primary biliary cirrhosis. * Eye disease: * Uncontrolled or potentially unstable diabetic retinopathy or maculopathy. * Abnormal lab results at screening: * eGFR \< 60 mL/min/1.73 m² (CKD-EPI). * ALT or AST \> 2.5 × upper limit of normal (ULN). * Total bilirubin \> 1.5 × ULN (except known Gilbert's syndrome). * Serum amylase or lipase \> 1.5 × ULN. * Fasting triglycerides \> 5.7 mmol/L. * TSH \> 1.5 × ULN. * Calcitonin ≥ 20 ng/L. * Hemoglobin \< 110 g/L (male) or \< 100 g/L (female).

Locations (46)

Central Research Associates - Flourish - PPDS

Birmingham, Alabama, United States

AES - DRS - Synexus Clinical Research US, Inc. - Birmingham

Birmingham, Alabama, United States

AES - DRS - Optimal Research Alabama - Huntsville

Huntsville, Alabama, United States

Ark Clinical Research - Long Beach

Long Beach, California, United States

Flourish Research - Walnut Creek - PPDS

Walnut Creek, California, United States

AES - DRS - Optimal Research Florida - Melbourne

Melbourne, Florida, United States

Tampa General Hospital

Tampa, Florida, United States

Conquest Research LLC - Winter Park

Winter Park, Florida, United States

Privia Medical Group Georgia, LLC - Albany - Javara - PPDS

Albany, Georgia, United States

Privia Medical Group Georgia, LLC - Savannah - Javara - PPDS

Savannah, Georgia, United States

Privia Medical Group Georgia, LLC - Thomasville - Javara - PPDS

Thomasville, Georgia, United States

AES - DRS - Synexus Clinical Research US, Inc. - Chicago

Chicago, Illinois, United States

AES - DRS - Synexus Clinical Research US, Inc. - Evansville

Evansville, Indiana, United States

Privia Medical Group, LLC - Kelly's Collaborative Care - Javara - PPDS

Silver Spring, Maryland, United States

Elixia Health - Springfield - Elixia - PPDS

Springfield, Massachusetts, United States

Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS

Pontiac, Michigan, United States

AES - DRS - Synexus Clinical Research US, Inc. - Edina - Minneapolis

Edina, Minnesota, United States

Mankato Clinic - East Main Street - Javara - PPDS

Mankato, Minnesota, United States

Hassman Research Institute - Berlin - CenExel - PPDS

Berlin, New Jersey, United States

Albuquerque Clinical Trials Inc

Albuquerque, New Mexico, United States

M3 Wake Research, Inc - M3 WR

Raleigh, North Carolina, United States

Unity Clinical Research

Oklahoma City, Oklahoma, United States

Monroe Biomedical Research Charleston

North Charleston, South Carolina, United States

M3 Wake Research - Dallas

Dallas, Texas, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

SMS Clinical Research, LLC - 400 W. Kearney St

Mesquite, Texas, United States

AES - DRS - Synexus Clinical Research US, Inc. - San Antonio

San Antonio, Texas, United States

Flourish Research - San Antonio - PPDS

San Antonio, Texas, United States

Privia Medical Group- North Texas - Stephenville - Javara - PPDS

Stephenville, Texas, United States

Conquest Research - Arlington

Arlington, Virginia, United States

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Poznaniu

Poznan, Greater Poland Voivodeship, Poland

Centrum Medyczne Pratia Bydgoszcz - PPDS

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne

Krakow, Lesser Poland Voivodeship, Poland

FutureMeds - Krakow - PPDS

Krakow, Lesser Poland Voivodeship, Poland

Gabinet Lekarski Robert Witek

Tarnów, Lesser Poland Voivodeship, Poland

METABOLICA Sp. z o.o

Tarnów, Lesser Poland Voivodeship, Poland

AES - DRS - Synexus Polska Sp. z o.o. Oddzial we Wroclawiu

Wroclaw, Lower Silesian Voivodeship, Poland

AES - DRS - Synexus Polska Sp. Z o.o. Oddzial w Lodzi

Lodz, Lódzkie, Poland

FutureMeds - Lodz - PPDS

Lodz, Lódzkie, Poland

FutureMeds - Warszawa Centrum - PPDS

Warsaw, Masovian Voivodeship, Poland

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Warszawie

Warsaw, Masovian Voivodeship, Poland

ETG Warszawa - PPDS

Warsaw, Masovian Voivodeship, Poland

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku

Gdansk, Pomeranian Voivodeship, Poland

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdyni

Gdynia, Pomeranian Voivodeship, Poland

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie

Częstochowa, Silesian Voivodeship, Poland

AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach

Katowice, Silesian Voivodeship, Poland

Clinical Research Directory

A Study of CX11 Tablets in Patients With Type 2 Diabetes Mellitus

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (46)